Application 040686

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETHOSUXIMIDE	ETHOSUXIMIDE	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040686-001	ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB		2008-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040686-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040686-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2008-05-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040686-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040686-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040686-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040686-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040686-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040686-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040686-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040686-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040686-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040686-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040686-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040686-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040686-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040686-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040686-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040686-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040686-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040686-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040686-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040686-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040686-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040686-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040686-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040686-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040686-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040686-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040686-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040686-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040686-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040686-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040686-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040686-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040686-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040686-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040686-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040686-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040686-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040686-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040686-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040686-001	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethosuximide	ETHOSUXIMIDE	Mylan Pharmaceuticals Inc.	19c924c2-f558-4c78-9277-2d7e0df2f505	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
ETHOSUXIMIDE	ETHOSUXIMIDE	Strides Pharma Science Limited	a4dbc665-4db1-4d0a-9630-5cd200ec4c82	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: ETHOSUXIMIDE generic name: ETHOSUXIMIDE
Ethosuximide	ETHOSUXIMIDE	Chartwell Governmental & Specialty RX, LLC.	a825265d-ace9-4463-a16d-f6d5e1e31188	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
Ethosuximide	ETHOSUXIMIDE	Chartwell RX, LLC	9812840a-004d-46fa-8414-7d04a384e06a	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
Zarontin	ETHOSUXIMIDE	Parke-Davis Div of Pfizer Inc	0e008f33-70a1-4bc6-b3a0-d45214418ab6	2026-05-25	Warnings, Adverse reactions	Name fallback generic name: ETHOSUXIMIDE
ETHOSUXIMIDE	ETHOSUXIMIDE	PAI Holdings, LLC dba PAI Pharma	8a5cc930-0b36-48a8-9ad0-de633b208742	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: ETHOSUXIMIDE generic name: ETHOSUXIMIDE
Ethosuximide	ETHOSUXIMIDE	Epic Pharma, LLC	a040dab2-0d70-4c02-a830-5ba1e3506a1b	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
Ethosuximide	ETHOSUXIMIDE	Epic Pharma, LLC	85c50760-98cc-4888-b27f-146937acc893	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
ETHOSUXIMIDE	ETHOSUXIMIDE	Chartwell RX, LLC	43fdfd16-c723-452a-9c1d-accf6f7c622e	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: ETHOSUXIMIDE generic name: ETHOSUXIMIDE
Ethosuximide	ETHOSUXIMIDE	Bryant Ranch Prepack	867b54c4-4ce4-4c00-a03b-f108f1000e29	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
Ethosuximide	ETHOSUXIMIDE	Bionpharma Inc.	efb047e8-0020-4504-97fa-6aa1af3af05e	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Ethosuximide generic name: ETHOSUXIMIDE
Zarontin	ETHOSUXIMIDE	Parke-Davis Div of Pfizer Inc	7bf3e616-45e8-4469-a75d-4d824ce951ea	2023-07-13	Warnings, Adverse reactions	Name fallback generic name: ETHOSUXIMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61748-025	Ethosuximide	Ethosuximide	VersaPharm Inc. - an Akorn Company	ANDA	Current
61748-025	Ethosuximide	Ethosuximide	Akorn	ANDA	Current
61748-025	Ethosuximide	Ethosuximide	Versapharm Incorporated	ANDA	Current
61748-025	Ethosuximide	Ethosuximide	Versapharm Incorporated	ANDA	Current